Regulatory Affairs Specialist

5 hours ago


Hong Kong, Central and Western District, Hong Kong SAR China Links International Full time

Job Description

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  • About the Role: We are seeking a highly skilled and detail-oriented individual to join our team as an Assistant Manager for Regulatory Affairs & BioMed Tech Startup Management.">
">Key Responsibilities:">
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  • Provide operational support and account management for biotech programs, ensuring smooth development and execution.">
  • Facilitate connections for start-up companies with relevant service providers, including Contract Research Organizations (CROs), regulatory authorities, and quality system developers, to meet clinical trial and regulatory requirements.">
  • Coordinate the application process for regulatory funding and assist companies with regulatory submissions, ensuring all processes comply with internal and external guidelines.">
  • Serve as secretary for major program meetings, including panel assessments, milestone evaluations, and client meetings, ensuring internal controls are in place for compliance.">
  • Conduct evaluations of program applications, arranging due diligence and assessment meetings, and providing input for continuous program enhancements.">
  • Contribute to the ongoing improvement of program SOPs and processes, supporting the continuous development of the ecosystem.">
  • Perform other related duties as assigned by the management team.">
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Requirements

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  • A bachelor's degree in life sciences, biomedical sciences, biomedical engineering, or other related fields, or an equivalent qualification.">
  • At least 5 years of work experience, preferably in regulatory affairs or project management in the medical devices, pharmaceutical, or biopharma industries.">
  • Experience in CRO/CDMO management, protocol development, Investigational New Drug (IND) filing, and regulatory submissions (FDA, NMPA, etc.) is an advantage.">
  • Knowledge or experience in clinical trials and clinical affairs, particularly in medical devices and pharmaceuticals, is a plus.">
  • Strong interpersonal, communication, and presentation skills. A proactive, self-motivated, and results-oriented approach.">
  • Proficient in spoken and written English and Chinese, including Mandarin.">
  • Candidates with higher education or professional qualifications and less experience will also be considered.">
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What We Offer

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  • A dynamic and innovative work environment within a leading hub for technology and innovation.">
  • A 5-day work week with competitive annual leave and additional special leave.">
  • Comprehensive medical benefits, including dental and annual check-ups from day one, with extended coverage for dependents.">
  • Access to professional training and career development opportunities.">
  • Convenient transportation options, with a bus network connecting various locations across the city.">
">

This is an exciting opportunity for an ambitious professional to contribute to the growth of biotech startups and make a significant impact in the life sciences sector.



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